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A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes

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Vertex Pharmaceuticals

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Type 1 Diabetes

Treatments

Drug: VX-264

Study type

Interventional

Funder types

Industry

Identifiers

NCT05791201
VX22-264-101
2022-003318-35 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).

Enrollment

17 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Clinical history of T1D with greater than or equal to (>=) 5 years duration
  • Participant is on a stable diabetic treatment
  • Consistent use of continuous glucose monitoring (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study

Key Exclusion Criteria:

  • Prior islet cell transplant, organ transplant, or cell therapy

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

VX-264
Experimental group
Treatment:
Drug: VX-264

Trial contacts and locations

15

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Central trial contact

Medical Information

Data sourced from clinicaltrials.gov

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